Service Dogs are trained to assist people with disabilities to accomplish tasks which permit the individual to be more functional in their home and social environment. Often the dogs are trained to help in the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field.

Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

The primary outcome measures are limitations of activities and quality of life. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

The World Health Organization Disability Assessment Scale II will define activity limitations. The WHO-DAS 2.0 is a structured 36-item instrument, which assesses difficulties in six domains of life during the last 30 days.

quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

The outcome measure will be the summary measures from the Veteran's Rand 12 item Health Survey (VR-12) as measured by both the Physical Component Summary and Mental Component Summary scores.

The outcome measure for PTSD severity will be the Posttraumatic Stress Disorder Checklist. PCL is a 20-item self-report measure of PTSD symptoms (in the past month) based on DSM-IV criteria with a 5-point Likert scale response format.

Along with the Health Economics Resource Center information healthcare utilization and costs will be collected from VA administrative data sets and from standard questions regarding non-VA outpatient and inpatient utilization.

Employment [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Employment outcomes will be examined with the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0.

Emotional Support Dog. Service Dog - an assistance dog specifically trained to perform tasks that are specific to the person's disability and has public access privileges.

-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.

Other: Emotional Support Dog

-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.

Active Comparator: 2

Service Dogs

Other: Service Dog or Emotional Support Dog

Emotional Support Dog. Service Dog - an assistance dog specifically trained to perform tasks that are specific to the person's disability and has public access privileges.

-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.

Other: Emotional Support Dog

-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.

Detailed Description:

Background: Service Dogs are trained to assist people with disabilities to accomplish tasks which permit the individual to be more functional in their home and social environment. Often the dogs are trained to help in the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field.

Study Primary Objective: To examine how limitations on activity and quality of life in Veterans with PTSD are impacted by the provision of a Service Dog versus an Emotional Support Dog.

Study Design: A three-year prospective randomized study is proposed which has two randomized arms. Arm one of the study will be Veterans (n=110) randomized to receiving a Service Dog, which has been trained for specific tasks to assist with the Veteran's disability. Arm two (n=110) of the study will be Veterans randomized to receive an Emotional Support Dog (a dog which provide emotional comfort). All Veterans, after confirmation of eligibility will be randomized to receive a Service Dog or Emotional Support Dog and will be observed a minimum of three months. During this period, Veterans will be required to participate in a Dog Care Course to ensure they are aware of the demands dogs place on humans. Once dogs become available, Veterans will be paired with a Service Dog or Emotional Support Dog. Follow-up will begin at one week post pairing to track any dog behavior issues, and will continue after pairing for 18 months. Primary outcomes to be examined include limitations on activity (as measured by the WHO- DAS 2.0), quality of life (measured by the VR-12). Secondary outcomes include PTSD symptoms (measured by the PCL), Suicidal ideation (Columbia-Suicide Severity Rating Scale); depression (PHQ-9) and Sleep (Pittsburgh Sleep Quality Index). In addition, health care utilization, anger management, employment and productivity will also be examined. This multi-site study will be conducted at three locations, Nationwide.

Enrolled in mental health services at VA and has attended at least one visit in the past 90 days prior to consent.

Agrees to remain in mental health treatment throughout the duration of the study

Ability to adequately care for a dog (physically and financially). Please note, an individual may have a physical impairment, (e.g., use a wheelchair), but Service Dogs will not be trained to accommodate for those disabilities.

Has lived in home for over six consecutive months and has suitable home environment to provide for a dog.

Home environment must be accessible for study staff

Willing to accept randomization outcome, thus willing to attend either a training session for potential receipt of Service Dog that lasts two weeks or a weekly obedience class to learn commands for their Emotional Support Dog.

Has someone to care for dog in the absence of Veteran

Agreement by others in home to have dog

Willing and able to travel (by air or car) to training site for pairing

Acceptance by dog vendors to receive dog. Note, additional criteria may be added because of the vendors who provide the dogs. At this time, the vendors are unknown. When the vendors are selected, eligibility criteria will be reviewed and consensus obtained on additional criteria.

Subject has no pets (cats, dogs or horses), but wants a dog.

Able to verbalize understanding of consent form, willingness to complete study questionnaires, and provide written informed consent

Exclusion Criteria:

Hospitalization for mental health reasons in the past 6 months

Aggressive behavior on the part of the Veteran that would make it unsafe for dog

Active suicidal or homicidal intent, or cognitive disabilities that would preclude safety of dog and ability to participate in the study

Suicide flag in VA medical record

Site PI identifies a social, mental or physical condition that prevents Veteran from either giving informed consent or participating in the study.

Participating in another research trial

Has the National CPRS flag for violent/disruptive behavior

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039843